C> r-c 2010

Tylenol"TYLENOL® SuppositoriesTylenol Suppositories 100 mg, 200 mg and 350 mg for Children

CompositionActive constituent: Paracetamol (acetaminophen).Ust of exciplsnts:Antioxidants: butyl hydroxyanisole (E 320). butyl hydroxytoluene (E321);Other excipients: colloidal silica, polysorbate 20, vegetable oil

Indications

For temporary relief of mild to moderate aches and pains such as:Headache - sore throat - tooth ache (including teething pain) - mild tomoderate aches and pains due to the common cold and flu.

Fever reduction (including post immunisation fever)

Dosage IApplication

'---'--.-""~S~~~:;~~s~~~;~h~fnTr~;~~~=:::!~~i~~~~~~,~e~,!;~n~ssubject to continuous medical supervision. In cases where the weightof the child is outside that of the associated age-range shown below,dosing should be based on body weight. The dosage interval for allages is 4 to 8 hours.

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1 suppository 3-4 x 1 supposrtories2-3 times a day (1,050-1,400 mgll day

Age Range Body Dose Maximum dose JdayWeight

3-12 Months100 mg Suppositories

3-6 months 5-7 kg 1 SUPPOSitOry 4 x 1 suppositories (4002-3 times a day mg)/day

6-12 months 7-10 kg 1 suppository 5 x 1 suppositories (5003-4 times a day mg) /d<¥t

1-6 Years200 mg Suppositories

1-3 years 10-15 kg 1 suppository 3-4 x 1 supposrtcoes2-3 times a day (600-800 mg) I day

3-6 years 15-22 kg 1 suppository 4-5 x 1 supposrtooes3-4 times a day (800-1,000 mg)/day

6-12 Years350 mg Suppositories

6-9 years 22-30 kg

SA· P160631SB R

Use In Renal DiseaseThere is no evidence that patients with renal disease have alteredhepatic metabolism,Well-controlled, prospective data indicate that paracetamol can beused in patients with moderete-to-severe.renat failure, with no dosageadjustmentInteractionsConcomitant administration of paracetamol and anticonvulsants atrecommended doses does not increase the risk of hepatotoxidty.

Undesirable EffectsAdverse drug reactions identified during post-marketing experiencewith therapeutic doses of paracetamol are listed below by frequencycategory as estimated from spontaneous reporting rates:

Immune System Disorders

Very rare «1/10,000, including isolated reports): AnaphylactJc reac-tion, hypersensitivity

Skin and Subcutaneous Tissue DisordersVery rare «1110,000, induding isolated reports): Urticaria, pruriticrash, rash

OverdoseParacetamol in massive overdosage may cause hepatic toxicity; there-fore prompt medical attention is critical even if there are no apparentsigns or symptoms. Early symptoms following a potentially bepatctcxrcoverdose may include: anorexia. nausea, vomiting, diaphoresis, pallorand general malaise. Clinical and laboratory evidence of hepatic toxic-ity may not be apparent until 48 to 72 hours post-ingestion. In children«12 years of age), an acute over dosage of less than 150 mg/kg hasnot been associated with hepatic toxicity. If more than 150 -200 mg/kgor an unknown amount was administered, obtain a plasma paracetamollevel as soon as possible, but no sooner than 4 hours following inges-tion. If the serum paracetamol level can be obtained within 8 hourspost-ingestion, initiating acetylcysteine treatment is not necessary untilthe result is obtained. However, if the estimated time post-ingestionapproaches 8 hours, aootytcysteine treatment should be initiated imme-diately. If an assay cannot be obtained and the estimated paracetamolingestion exceeds 150 mg/kg, dOSingwith acetylcysteine should beinitiated and continued for a full course of therapy.

Other InformationDrugs containing paracetamol must not be administered to children whohave consumed alcohol in error.

Shelf LifeTylenol Children must not be used after the date marked 'EXP' on thecontainer.

Special Precautions for Storage00 not store above 3O·CKeep blister in the outer carton

Instructions for application

Lubricate the tip of the suppository with either water or a water-basedlubricant

.- -l_9-;",;;'2;,;Y:,;ea,;;rs,;;...-+..:30-4.:....:.:.0..:k9'-.+:1"'So;U"'Ppo••••SI:;;'°r:.;,.•••.. +5-6rn."X"'1iSU;;;,POiPOSn;~S Special Precautions for Handlin~'="====~====",... .,L -'- ....L. "-_·,_""""_'""_",mg_)7_o_,,,,_"--,I- Tytenol Children's Suppositories become fluid or soften at temperature

exceeding 35·C. To restore the suppositories rapidly to an application-ready state, cool them briefly by holding them under running cold water.This does not alter the quality of the suppositories. When cooling aseooosatory. make sure that the tip is pointing downwards. This ensuresthat the suppositories regain their firmness in the form necessary foruseInsert the lubricated tip of the supposrtory up IOta the rectal opemng.

Push it in using your index finger (or small finger for younger childrenand hold against the rectal wall for a few seconds. this will keep it inplace.

ContraindicationsIf allergic to paracetamol (acetaminophen) or any of the formulationexciplents.

Special Warnings and Special Precautions "for Use

Do not use with any other product containing paracetamol (acetami-nophen).

00 not exceed recommended dose.

If pain or fever persists or gets worse, or if new symptoms occur, aphysician should be consulted promptly. These could be signs of aserious condition.

Keep out of reach of children.

Overdose waming: Taking more than the recommended dose (over-dose) may cause liver damage. In case of overdose, even if you donot notice any signs or symptoms, get medical help immediately.Consult the doctor in case of severe liver or kidney prcosem beforeusing this product.

Use in Hepatic DiseaseParacetamol can be used in patients with liver disease and has beenstudied in both one-time single and multiple doses in adult patients withchronic stable liver disease. Following a single (10mgl kg) dose ofparacetamol, the pharmacokinetic profile in paediatric patients with mild,moderate or severe liver disease were not significantly different

PackagesTyienol Suppositories 100 mg: (BOXof 10's)Tytenoi Suppositories 200 mg: (Box of 10's)Tyteoo Suppositories 350 mg: (Box of 10's)

ManufacturerLusomedicamenta Sociedade Tecnica sarrneceuuce. SAEstrada Consiglieri Pedroso 69 BQueluz de BalXo, 2730-055 BarcarenaPortugal

Marketing Authorisation Holder in SwitzerlandJanssen-Cilag AG: Sihlbruggstrasse 1116340 Baar, SwitzerlandOate of Revision of the TextMarch 2010

This is a Medicament• Medicament is a product which affects your health andits consumption contrary to instructions is dangerous for you.

• Follow strictly the doctor's presaiption, the method of use and theinstructions of the pharmacist who sold the medicament

• The doctor and the pharmacist are the experts in medicines,their benefits and risks.

• Do not by yourself interrupt the period of treatment prescribed for you• Do not repeat the same prescription without consulting your doctor.

Council of Arab Health MinistersUnion of Arab Pharmacists

Keep all medicaments out of reach of children.